Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
All animals are equal, but some animals are more equal than others	Helmut	2018-10-09 14:33	0		201
Redesign of the EMA’s website	Helmut	2018-10-08 12:20	0		219
FDA: Dissolution Testing and Acceptance Criteria for IR…	Helmut	2018-09-03 14:46	0		207
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	Helmut	2018-08-09 10:52	0		391
EMA: Q&A Update EMA: Q&A Update The early bird gets the worm The early bird gets the worm but Lambda Therapeutic Ltd.? Lambda Therapeutic Ltd.? EMA: Q&A Update; Expected studies for Quetiapine PR Tablets	Helmut	2013-11-15 13:53	6	2018-08-06 14:42	7,253
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	Helmut	2018-06-26 14:40	3	2018-08-03 16:52	1,401
New FDA BMV guideline What a monster! What a monster! Two Versions: May 21 & May 24 Repeats as part of investigations, ja oder nein? Repeats as part of investigations, ja oder nein? Two Versions: May 21 & May 24 Requirements ⇒ recommendations Requirements ⇒ recommendations	Ohlbe	2018-05-21 16:28	8	2018-08-02 22:59	1,854
ICH M9 Draft	Helmut	2018-07-16 14:49	0		448
Updated TPD BE guidances Updated TPD BE guidances Canada-Comparative bioavaiability standards	BRB	2018-06-18 22:53	2	2018-06-27 12:36	760
New EMA guideline: Handling and shipping of IMPs	Helmut	2018-05-24 15:45	0		684
Shenanigans	ElMaestro	2018-04-15 14:50	0		545
Revision of the BE-GL? ...and much more Postponed: New target date Q4 2018 Postboned: New target date Q4 2018 Postponed: New target date Q4 2018	Helmut	2017-04-29 15:26	4	2018-02-15 13:32	2,589
Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud Fraud One more One more Fraud Kill the messenger Kill the messenger Kill the messenger Kill the messenger	Helmut	2016-04-24 13:14	18	2018-02-15 01:28	11,856
Brexit Brexit	Helmut	2017-12-12 12:50	1	2018-01-10 11:56	1,630
Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Were physicians/patients aware of the change in the formulation? Levothyroxine: A black swan? Levothyroxine: A black swan? Levothyroxine: A black swan?	Helmut	2017-11-26 12:51	8	2017-11-28 08:53	9,978
Whistleblowers, stand up! Whistleblowers, stand up! Whistleblowers, stand up! This isn't about whistleblowers This isn't about whistleblowers This isn't about whistleblowers	Helmut	2017-05-23 14:12	5	2017-05-25 12:37	2,600

Bioequivalence and Bioavailability Forum 10:17 CEST